Promising Clinical Trial for Mesothelioma Treatment Comes to U.S.

A press release from MolMed S.p A. reports “the expansion in the United States of a pivotal Phase III trial of its investigational anticancer drug NGR-hTNF in malignant pleural mesothelioma,”  Market Watch, a digital publication associated with the Wall Street Journal , announces.  According to the press release out of Milan, Italy, “treatment of the first patient” is scheduled to be held “at one of the most prestigious US Universities in New York.” According to the news source, this drug is a vascular targeting agent used to “selectively target tumor vasculature,” meaning it is designed to damage the blood vessels of tumors and cause them to die. This drug has been in development for use as a “monotherapy,” as well as a combination therapy, which would see its integration into several other treatment methods such as surgery, chemotherapy, and radiation therapy. The combined use of several treatments is also known as a multimodal approach to treatment and is a common approach for mesothelioma Market Watch explains that MolMed, the biotechnology company responsible for developing NGR-hTNF, is “focused on research, development, and clinical validation of novel antitumor therapies.” This company is headquartered at the San Raffaele Biomedical Center Park located in Milan, Italy, the news source explains. Other trials studying the same drug are already underway in Europe, Market Watch reports, and the company hopes to “eventually involve over 40 centres worldwide,” with results expected in 2013. According to the news source, this current trial is not the first time NGR-hTNF has been investigated for its anticancer properties. Ongoing Phase II trials for NGR-hTNF include those aimed at treating non-small-cell lung cancer, soft tissue sarcomas, and ovarian cancer, in addition to mesothelioma. Market Watch also reports that there are other completed Phase II trials that involved NGR-hTNF in the treatment of a number of cancers, including mesothelioma. Currently, the press release explains that “NGR-hTNF has been granted Orphan Drug designation for the treatment of mesothelioma and liver cancer both in the European Union and the United States.” The press release notes this trial, titled “Phase III Trial NGR015,” is classified as a “pivotal randomized, double-blind, placebo-controlled, multicentre Phase III trial,” and “expects to enroll 390 adult patients affected by malignant pleural mesothelioma with disease progressing after standard pemetrexed-based chemotherapy.” Market Watch also reports that the trial will have both primary and secondary endpoints including “overall survival” and “progression-free survival, disease control rate, safety and patient’s quality of life.” The establishment of this trial in the United States follows IND clearance from the FDA. In addition to allowing patients access to advanced medical care, clinical trials such as the one reported in this Market Watch press release give hope to all mesothelioma patients. Even though no known cure currently exists for this form of cancer, new drugs aimed at improving survival rates and quality of life are constantly in development. Those patients that participate in clinical trials such as this one have the opportunity to not only assist in their own treatment process, but in the overall progression of treatment for countless patients yet to be diagnosed.
References:
  • American Cancer Society
  • Market Watch Staff. (October 25, 2011) “MolMed Expands Phase III Trial of NGR-hTNF for the Treatment of Mesothelioma in the United States.” Retrieved on October 25, 2011 from Market Watch.
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